Addition of Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation to an Education and Exercise Program in Subjects With Chronic Pain Due to Knee Osteoarthritis
- Conditions
- Chronic PainOsteo Arthritis Knee
- Interventions
- Device: transcranial direct current stimulation (tDCS)Device: TENSBehavioral: Exercise and General Education
- Registration Number
- NCT05138471
- Lead Sponsor
- Universidad de Murcia
- Brief Summary
Knee osteoarthritis has a very high prevalence in the population over 50 years of age. Patients with osteoarthritis often suffer from chronic pain that becomes disabling, affecting both quality of life and mental and physical health. This pathology has also been linked to maladaptive plasticity in the brain, which can contribute to chronic pain. Therapies with neuromodulatory approaches, such as transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (TENS), have been used therapeutically to counteract the maladaptive plasticity of the brain.
Transcranial therapy and TENS can be a possible effective treatment in the rehabilitation services of the health system for the improvement of chronic pain and quality of life in different pathologies, such as chronic low back pain, fibromyalgia or knee and hip osteoarthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- Adults over fifty years of age with a diagnosis of knee osteoarthritis by radiography.
- Chronic pain of more than six months, compliance with the diagnostic criteria for knee osteoarthritis according to the Osteoarthritis Research Society International (OARSI) guideline:
- Pain in Analog Visual Scale more than 4/10
- Matutinal less than 30 minutes
- Absence of hyperthermia upon palpation in the joint
- Alteration of the bone image
- Crepitus
- Patients who can provide low-quality or biased information discriminated by the Mini-Mental State Examination (Score less than 24).
- Severe hearing, visual or sensory impairment or comorbidities that prevent the correct completion of the questionnaires and mobility activities.
- Patients who have undergone knee replacement surgery on the contralateral knee.
- Patients who have received intervention (infiltration, blockages, etc...) in the last 6 weeks.
- Pain due to tendinopathy, knee fracture, low back pain radiating to the knee, or fibromyalgia.
- Patients who decline to participate out of fear or denial of therapy.
- Severe heart disease that prevent exercise.
- Body Mass Index above 45.
- Patients with neuropsychiatric disorders (schizophrenia, epilepsy or bipolar disorders) or taking medication for these conditions (antiepileptic drugs).
- Patients with metallic implants in the area (skull or knee).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tDCS Active vs TENS Active transcranial direct current stimulation (tDCS) - tDCS Active vs TENS Active TENS - tDCS Active vs TENS Active Exercise and General Education - tDCS Active vs TENS Placebo transcranial direct current stimulation (tDCS) - tDCS Active vs TENS Placebo Exercise and General Education - tDCS Placebo vs TENS Placebo Exercise and General Education -
- Primary Outcome Measures
Name Time Method Chronic Knee Pain Through study completion, an average of 1 year. The Visual Analogic Scale will be used to assess the impact on chronic knee pain. The values range from 0 to 10 (0 = No pain, 10 = the worst pain).
- Secondary Outcome Measures
Name Time Method Coordination and Balance Through study completion, an average of 1 year. Timed Up and Go Test (TUG), less than 10 seconds (low risk of falls) more than 20 seconds (high risk of falls).
Function and Quality of Life Through study completion, an average of 1 year. The Western Ontario and McMaster (WOMAC) scale will be used to assess pain, function, and quality of life in knee osteoarthritis and range from 0 to 96 (higher score, worst outcome).
Force Through study completion, an average of 1 year. Using a dynamometer for quadriceps muscle (measurement in Kg, higher score means better outcome).
Balance Through study completion, an average of 1 year. A short physical performance battery (SPPB) will be used to measure balance. SPPB ranges from 0 (worst) to 12 (best).
Gait properties. Through study completion, an average of 1 year. 6 Minutes Walk Test (meters) measure exercise tolerance, less than 350 meters is high risk of death in some patients. More meters, more score.
Central Sensitization Through study completion, an average of 1 year. 8Central Sensitization Inventory (CSI) range from 0 to 100 (higher values are worst outcome)
Kinesiophobia Through study completion, an average of 1 year. The Tampa Scale of Kinesiophobia (TSK) range from 11 to 44 (higher values are worst outcome).
Uncertainly Through study completion, an average of 1 year. Mishel's Uncertainly Scale (MUIS) range from 55 to 121 (more score, greater uncertainly, worst outcome).
Catastrophizing Through study completion, an average of 1 year. The Pain Catastrophizing Scale (PCS) range from 0 to 52 (more score, greater catastrophizing, worst outcome).
Trial Locations
- Locations (1)
University of Murcia
🇪🇸Murcia, Spain